FDA’s Generic Drug Program: Decreasing Time to Approval and Number of Review Cycles H Chazin, J Woo, J Han, S Grosser, J Luan Therapeutic Innovation & Regulatory Science 54, 758-763, 2020 | 6 | 2020 |
Abbreviated new drug applications: generic drug user fee amendments act analysis of application quality metrics J Woo, J Luan, Z Li, S Grosser, J Peters, H Chazin Therapeutic Innovation & Regulatory Science 53 (5), 696-700, 2019 | 4 | 2019 |
Drug information association pharmacovigilance and risk management strategies 2017: Overview of the generic drug program and surveillance HD Chazin, JR Peters, DM Catterson, JL Osterhout, LM Forsyth, JE Lee, ... Therapeutic innovation & regulatory science 53 (2), 249-253, 2019 | 3 | 2019 |
The author (s) pharmacovigilance and risk management strategies 2017: overview of the generic drug program and surveillance HD Chazin, JR Peters, DM Catterson, JL Osterhout, LM Forsyth, JE Lee, ... Therapeutic Innovation & Regulatory Science 53, 249-253, 2019 | 2 | 2019 |
Global Postmarket Pharmacovigilance: A Generic Drug Perspective T Dalsey, E Kim, H Chazin, S Ibrahim Therapeutic Innovation & Regulatory Science 57 (6), 1180-1189, 2023 | | 2023 |
Assessment of Transfusion-Related Acute Lung Injury after Red Blood Cell, Plasma and Platelet Administration: Initial Results in the Sentinel System CC Fuller, C Zinderman, SA Anderson, C Balsbaugh, N Bryant, H Burgess, ... PHARMACOEPIDEMIOLOGY AND DRUG SAFETY 26, 385-385, 2017 | | 2017 |
Expansion of the US FDA Sentinel System to inpatient blood transfusion data from Hospital Corporation of America: new surveillance options CC Fuller, MA Baker, C Spencer-Smith, SA Anderson, C Balsbaugh, ... PHARMACOEPIDEMIOLOGY AND DRUG SAFETY 26, 8-9, 2017 | | 2017 |